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American Academy of Dermatology honors Dr. Nada Elbuluk as National “Patient Care Hero”

Nada Elbuluk, MD, MSc, FAAD was honored as an American Academy of Dermatology (AAD) Patient Care Hero for her work swiftly diagnosing and treating a patient’s severe scarring condition.

When Los Angeles area resident Julie Wright noticed her hair was thinning, she turned to dermatologist Dr. Elbuluk for help. After a biopsy, Dr. Elbuluk diagnosed Ms. Wright with central centrifugal cicatricial alopecia (commonly referred to as CCCA).

Dr. Elbuluk started Ms. Wright on a thorough treatment plan, including topical and oral medications, as well as steroid injections into the scalp to help stop the progression of her condition and prevent it from spreading. Ms. Wright’s CCCA is now under control.

“The number one goal after diagnosing scarring alopecia is to prevent it from progressing,” explains Dr. Elbuluk, a dermatologist with Keck Medicine of USC and director of the USC Skin of Color and Pigmentary Disorders Program. “I was thankful we caught Julie’s case early and were able to really make a difference for her.”

CCCA is estimated to affect 15 percent of Black women. Studies suggest the condition could be tied to a specific gene or a disease that causes inflammation in the body. However, its exact cause is unknown.

Under Dr. Elbuluk’s direction, Ms. Wright underwent an allergy test to find potential triggers of her CCCA. After the results showed that Ms. Wright was allergic to a common chemical in hair dyes, she stopped coloring her hair.

The AAD created the Patient Care Heroes program to recognize physicians who transform patients’ lives by utilizing their expertise and collaborating with other physicians.

New Inclusive Derm Atlas Launches

Allergan Aesthetics, an AbbVie company, and SkinBetter Science through their DREAM (Driving Racial Equity in Aesthetic Medicine) initiative are supporting the development and distribution of The Full Spectrum of Dermatology: A Diverse and Inclusive Atlas, a dermatology atlas that will display images of the most commonly seen dermatology conditions in an array of skin tones.

Developed by co-editors Misty Eleryan, MD, MS, and Adam Friedman, MD, published by SanovaWorks and Educational Testing & Assessment Systems, the Atlas includes high-quality images taken by dermatologists trained in medical photography which provide side-by-side images of the most commonly seen dermatology conditions in a full spectrum of skin tones.

New Global Initiative Aims to Improve Eczema Care For ALl

The new Global Patient Initiative to Improve Eczema Care (GPIIEC) is a global collaboration to establish a common “yardstick” to assess the responsiveness of health systems to the needs of patients with eczema and their caregivers around the globe. The global initiative, representing 11 patient organizations and supported with funding from LEO Pharma launched on World Eczema Day in September.

The partnership has identified the elements of health care provision that matter most to patients and caregivers and established indicators by which to measure them across eight developed nations. Global Parents for Eczema Research (GPER) is the lead organization for the initiative. The group’s 2020 literature review found that across the eight countries, eczema patients and caregivers encounter similar challenges: limited treatment options, obstacles to accessing specialists and treatments, and approaches to eczema care and management that ignore the full impact of the condition, particularly the significant psychosocial burden.

The GPIIEC will collect and analyze data from primary surveys and secondary data across the eight countries to create a comparative global dashboard of eczema care. The joint effort will lead to data-driven insights about each country’s areas of strength and weakness in meeting the needs of people who live with eczema and result in policy recommendations for addressing them, organizers say.

“We are thrilled to join forces to define what better care looks like for the people we serve,” says Rachael Manion, Executive Director of the Canadian Skin Patient Alliance. “Working together, we’ve learned that issues we face are similar across countries and continents. It’s time to advocate for change, and defining that change is a critical first step.”

“We need patient centered measures for this condition, similar to those that exist for other chronic diseases, so that we can assess progress and chart a path towards improvement,” says Melanie Funk, Managing Director with Eczema Support Australia.

FDA Approves Amendment to Avita’s Vitiligo Trial Design

Avita Medical, Inc. will move forward with an amended pivotal clinical trial evaluating the safety and effectiveness of the RECELL System for the repigmentation of stable vitiligo lesions to a streamlined single-arm trial design, now that the FDA has approved the trial modification. The company’s strategic decision to pursue a single cell suspension formulation (1:20 expansion ratio) is based on data from other research efforts that suggest the improbability of meaningful clinical performance differences amongst the three cell suspensions in the initial pivotal clinical trial design.

“The simplified study design and reduced number of study subjects reflects confidence both in the exceptional safety profile of RECELL and in the anticipated high incidence of repigmentation with RECELL treatment, as we have seen in 11 peer-reviewed publications and in the treatment of more than 1,000 patients outside the US,” says Dr. Mike Perry, Chief Executive Officer of Avita Medical. “The design change allows this program to progress in a timely and cost-effective manner toward bringing a novel therapeutic option to an underserved population. Our ongoing multi-media outreach and clinical and advocacy group referral programs are generating significant interest in the trial. The program is on track, and we continue to believe we could be in a position to enter the US market with the vitiligo indication, following successful completion of the clinical trial, as early as the second half of calendar year 2023.”

The multi-center pivotal study includes 15 clinical sites to assess the safety and effectiveness of the RECELL System in treatment of depigmented vitiligo lesions in patients whose vitiligo is stable, meaning they have not had new vitiligo lesions or lesions that have expanded for at least one year. The primary effectiveness evaluation is based on a comparison of the incidence of successful repigmentation with RECELL versus that of a standard of care control. Long-term durability data (assessing sustained repigmentation over 52 weeks) will be collected.

Each site is required to complete a run-in treatment as part of study initiation. Subjects treated in the earlier version of the pivotal clinical trial will be counted as part of the run-in cohort. After run-in, 23 subjects will be treated and evaluated in the final pivotal cohort. As with the previous design, an interim analysis will be conducted on 24-week data for approximately half of the subjects to evaluate sufficiency of the sample size, with a possible increase to sample size as needed (up to 46 subjects).

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